Welcome!
My name is Misti Ault Anderson, and I work in OHRP's Division of Education and Development.
This tutorial was created to help explain some of the requirements relating to IRB membership.
It reviews the requirements for IRB membership set out in the HHS regulations for the protection
of human subjects at 45 CFR Part 46, and answers some common questions.
After completing this tutorial, you should have a better understanding of the regulations
regarding IRB membership and how to apply them.
Let's get started!
An Institutional Review Board, or IRB, is a committee that monitors and protects the
rights and welfare of human subjects in research.
IRB review is a core component of human subjects protections under the HHS regulations.
The IRB determines whether the reviewed research activities meet regulatory requirements and
standards prior to and throughout the course of the research.
The weight of this responsibility means that the selection of members to serve on the IRB
should be thoughtfully considered, with a particular emphasis on their experiences and
perspectives.
The regulations require each IRB to have at least five members with varying backgrounds.
The IRB must be sufficiently qualified through the experience, expertise, and diversity of
its members to review the institution's research activities.
Relevant considerations include training and education, race, gender, cultural background,
and sensitivity to community attitudes.
In addition to a diversity of experience and perspectives, the IRB, as a whole, must be
able to review proposed research in terms of institutional commitments and regulations,
applicable laws, and standards of professional conduct and practice.
This means that its membership must include people who are knowledgeable in these areas.
An IRB needs to possess the professional competence to determine the acceptability of proposed
research with respect to regulations and policies, which includes whether the design and methodology
of the proposed research is ethically appropriate.
It is expected that the IRB will have the appropriate expertise to meet the membership
requirements with respect to the type of research it regularly reviews.
For example, an IRB that routinely reviews psychology research would be expected to include
one or more members with an expertise in that area.
Similarly, if an IRB regularly reviews research involving vulnerable populations, it should
have one or more members who have knowledge of and experience working with those populations.
To help ensure the IRB has the necessary expertise and diversity, the regulations put forth some
minimum membership requirements.
As noted earlier, there must be at least five members.
Of these, each IRB must include: at least one scientist, at least one nonscientist,
and at least one member who is not otherwise affiliated with the institution.
Institutions must indicate in the membership list whether members are scientists or nonscientists,
and whether or not they are affiliated with the institution.
In addition to the other categories of members, if an IRB oversees a study involving prisoners,
as defined under Subpart C, at least one member of the IRB must be a prisoner or a prisoner
representative with the appropriate background and experience to serve in that capacity.
OHRP recommends that a prisoner representative have a close working knowledge, understanding,
and appreciation of prison conditions from the prisoner's perspective.
If a particular proposal is reviewed by multiple IRBs, which may occur for a cooperative research
project, only one of the reviewing IRBs needs to satisfy this requirement.
Note that when reviewing research involving prisoners, a majority of the IRB members (excluding
the prisoner member) must not be associated with the prison(s) involved, outside of their
membership on the IRB.
Each IRB must have at least one designated scientist member.
This member's primary concerns are in scientific areas.
This means at least one member must be able to review research activities from a scientific
perspective.
This member should be able to provide meaningful insight about the science, such as the scientific
validity of the hypothesis or proposed methodology.
When considering whether an individual fulfills this requirement, think about whether their
professional training, background, and occupation equip them to review research activities from
the standpoint of a scientist working in the biomedical or socio-behavioral disciplines.
If so, that person might be a good choice to fulfill this requirement.
Linda studied philosophy in college and later earned a Master's Degree in Public Health.
She currently conducts epidemiological studies on infectious diseases with major public health
implications at a state university.
Is she qualified to serve as the scientist member on her university's IRB?
Likely yes.
Regardless of Linda's undergraduate degree in the humanities, her postgraduate training
in public health and her experience in conducting research in infectious diseases would likely
qualify her to serve as a scientist member on the IRB.
Each IRB must also have at least one designated nonscientist member.
This member must be a person whose primary concerns are in nonscientific areas.
Their professional training, background, and occupation should indicate they are likely
to review research from a perspective outside the realm of biomedical or socio-behavioral
science.
This requirement helps ensure that there will be discussion of diverse perspectives and
consideration of a broad range of issues that may affect research subjects.
Peter has a PhD in Social Work and was trained in the scientific method for his dissertation.
However, for the past 10 years, Peter has worked to secure access to public benefits
for underserved immigrant communities.
The IRB chair wants to recruit him as a nonscientist member.
Is Peter eligible for the role?
Likely yes.
Even though Peter has received training in the scientific methodology, his professional
experience includes no direct involvement in any scientific work.
It's reasonable to assume that Peter will be inclined to view research from a standpoint
outside of any scientific discipline.
Thus, he is likely eligible to serve as a nonscientist member of the IRB.
Each IRB must also have at least one designated unaffiliated member.
The unaffiliated member must not be affiliated with the institution, aside from serving on
the IRB.
This member also must not be someone who is an immediate family member of a person affiliated
with the institution.
OHRP considers spouses, parents, and children to be immediate family members.
Anyone who is affiliated or is an immediate family member of an affiliated person cannot
serve in this role.
For example: part-time or full-time employees, current students, members of any governing
panel or board of the institution, paid or unpaid consultants, healthcare providers holding
credentials to practice at the institution, and volunteers working at the institution
on business unrelated to the IRB are all considered "affiliated," and as such, they or their
immediate family members cannot fulfill the unaffiliated member requirement.
Some limited institutional associations still permit persons to serve as an unaffiliated
IRB member.
Examples include: past or current patients of the institution, past or current subjects
in research conducted by the institution, former students of the institution, infrequent
and small donors to the institution, or former or retired employees not receiving benefits
from the institution, such as a pension, housing, or health care.
Such individuals could serve as unaffiliated members of the IRB.
Note that paying unaffiliated members for their IRB service does not make them affiliated.
Although the unaffiliated member is often referred to as the community member or community
representative, the regulations call for an "unaffiliated" member, and don't specify
that this member represents any particular community.
The regulations require an individual who is not otherwise affiliated with the institution.
For example, a hospital chaplain may be an active and vocal community advocate but if
she is employed by the hospital, she cannot be the unaffiliated member on the hospital's
IRB, nor could an immediate family member such as her spouse.
However, she could serve as a nonscientist member.
Note that the regulations allow for a member to fulfill more than one role.
For example, one person could serve as both the unaffiliated member and the nonscientist
member.
Dr. Jones worked as a pediatrician at your research medical center for three years prior
to her retirement.
She does not currently maintain any ties with the institution.
As the IRB Chair, you would like to recruit her to serve as the unaffiliated member (or
what many refer to as the "community member") of your IRB.
Is Dr. Jones eligible for this role?
Likely yes.
Dr. Jones is eligible to be considered as an unaffiliated member of your institution's
IRB if she is not receiving any benefits from the institution such as retirement, pension,
or healthcare benefits and does not have any other affiliation with the institution.
An IRB administrator who meets the membership requirements may also serve as a member, provided
the administrator is included on the IRB membership list (as required for IRB members in general).
Note that an IRB chair is necessarily a member of the IRB.
If an IRB regularly reviews research involving populations vulnerable to coercion or undue
influence, such as children, prisoners, individuals with impaired decision-making capacity, or
economically or educationally disadvantaged people, consideration must be given to including
as an IRB member one or more individuals who are knowledgeable about and experienced in
working with these populations.
An IRB may decide that reviewing a particular research proposal or set of activities requires
a specific area of expertise not provided by its membership.
When this occurs, it may invite individuals with the necessary competence to supplement
the IRB's experience and assist with review.
For example, someone with a particular expertise in epidemiology or pediatric oncology might
be needed to review a specific clinical protocol.
Or an individual who has experience with and an understanding of a particular community's
norms may be asked to provide input on a study's recruitment strategy.
Outside experts don't need to be present for all aspects of discussion, and their participation
can take various forms, such as in-person attendance or teleconference with a convened
meeting, or providing written or oral advice in advance of the meeting.
However, participation of non-member experts in a convened meeting must be documented in
the minutes.
It is important to remember that non-member experts may not vote with the IRB.
IRBs may designate alternates for some or all of their primary members to ensure that
full board meetings can be convened, even if one or more of the primary members are
unavailable or lack the necessary expertise.
Although how an institution selects and identifies alternate members is left to the institution's
discretion, the requirements regarding the number and type of members that must be present
at a meeting must still be met.
For example, if no designated nonscientist member can attend a meeting, the alternate
who attends must also be a nonscientist.
The HHS regulations do not address term limits or length of service for IRB members or chairpersons.
It is up to the institution or the organization operating the IRB as to whether and how it
develops policies regarding length of service, the staggering of term limits, or balancing
continuity of experience with the inclusion of new perspectives and expertise.
That concludes this review of the IRB membership requirements.
We hope you found it helpful.
We've focused on the key ideas here, but encourage you to consult the regulations for
more detailed information.
Visit OHRP's website, www.hhs.gov/ohrp, for additional information.
Thank you!
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